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IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II

Award Number: R44ES031881
ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/10/2023
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II - Abstract Currently, the Draize live rabbit eye test is the benchmark to distinguish consumer products and materials that are safe from those that are hazardous and can cause mild, moderate, or severe ocular damage. However, new laws are currently being, or are planned to be, implemented in California, the United States, and the European Union to ban the use of animals for ocular irritation testing. Despite this fact, there is currently no single nonanimal test or combination of nonanimal tests that can accurately classify all levels of ocular irritants and corrosives. It is of particular concern that all nonanimal tests generally overpredict the least damaging class of ocular irritants and cannot determine (or determine with low sensitivity) the most extreme class for which they have sensitivity rates as low as 50%. More importantly, none of the currently validated alternative tests can detect irritants that require proper safety labeling (GHS Cat. 2A) or those that cause irritation that lasts up to 21 days but then clears without causing permanent corneal damage. This target classification represents a critical UNMET NEED for correctly informing and advising consumers and manufacturers about product safety. We have recently developed and tested a new method, the in vitro depth of injury eye irritation test (IVD EIT), to detect all classes of irritants with high sensitivity and specificity. The purpose of this application is to further develop the IVD EIT with the long-term goal of providing a service and/or kit for the accurate classification of ocular irritants to meet this UNMET NEED for a nonanimal ocular irritation test to be used to label product and chemicals and hence ensure safe handling practices. 1


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $1,002,666 )
2024	2024	LEBRUN LABS LLC	3301 E MIRALOMA AVE	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	000	2	12/15/2023	SUPPLEMENT FOR EXPANSION	$71,112
2024	2024	LEBRUN LABS LLC	3301 E MIRALOMA AVE STE 194	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	001	3	4/19/2024	NON-COMPETING CONTINUATION	$913,819
2024	2024	LEBRUN LABS LLC	3301 E MIRALOMA AVE STE 194	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	002	3	4/23/2024	SUPPLEMENT FOR EXPANSION	$17,735
														Subtotal = $1,002,666

Issue Date FY: 2023 ( Subtotal = $878,010 )
2023	2023	LEBRUN LABS LLC	3301 E MIRALOMA AVE	ANAHEIM	CA	92806	ORANGE	USA	Environmental Health	000	2	5/9/2023	COMPETING CONTINUATION	$878,010
														Subtotal = $878,010

Grand Total All Awards = $1,880,676

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IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II

Award Number: R44ES031881

ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/10/2023

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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